Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | SYNRIBO | — | 2014-02-10 | fda.gov ↗ |
| Approved | US (FDA) | SYNRIBO | — | 2012-10-26 | fda.gov ↗ |
Trials 59
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2021-04-12 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Releases Preclinical Data of Its Core Drug Candidates at AACR Annual Meeting 2021, with Results Signifying the Potential of Multiple Combination Therapies in Cancer ascentage.com ↗
BCL-2 inhibitor APG-2575 and homoharringtonine (HHT) synergistically induces apoptosis and inhibits tumor growth in preclinical models of acute myeloid leukemia and myelodysplastic syndromes (AML/MDS) |
| 2021-03-10 | Ascentage Pharma Group Inc. | Results Ascentage Pharma to Present the Latest Results from Six Preclinical Studies at AACR Annual Meeting 2021 ascentage.com ↗
BCL-2 inhibitor APG-2575 and homoharringtonine (HHT) synergistically induces apoptosis and inhibits tumor growth in preclinical models of acute myeloid leukemia and myelodysplastic syndromes (AML/MDS) |
| 2014-05-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory FDA Approves Teva’s SYNRIBO® (Omacetaxine Mepesuccinate) for Injection for Home Administration tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved SYNRIBO® (omacetaxine mepesuccinate) for injection, for subcutaneous use, to include home administration, and also approved a related Medication Guide and Instructions for Use. |
| 2014-02-13 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Full FDA Approval of SYNRIBO® (Omacetaxine Mepesuccinate) for Injection tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval of SYNRIBO® (omacetaxine mepesuccinate) for injection. |
| 2012-10-26 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives Approval For SYNRIBOTM (Omacetaxine Mepesuccinate) for Injection tevapharm.com ↗
SYNRIBO received an accelerated approval |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-04-12 | Ascentage Pharma Group Inc. | Ascentage Pharma Releases Preclinical Data of Its Core Drug Candidates at AACR Annual Meeting 2021, with Results Signifying the Potential of Multiple Combination Therapies in Cancer ascentage.com ↗ |
| 2021-03-10 | Ascentage Pharma Group Inc. | Ascentage Pharma to Present the Latest Results from Six Preclinical Studies at AACR Annual Meeting 2021 ascentage.com ↗ |
| 2014-05-05 | Teva Branded Pharmaceutical Products R&D, Inc. | FDA Approves Teva’s SYNRIBO® (Omacetaxine Mepesuccinate) for Injection for Home Administration tevapharm.com ↗ |
| 2014-02-13 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Full FDA Approval of SYNRIBO® (Omacetaxine Mepesuccinate) for Injection tevapharm.com ↗ |
| 2012-10-26 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Receives Approval For SYNRIBOTM (Omacetaxine Mepesuccinate) for Injection tevapharm.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 70 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Homoharringtonine | “A Single-arm, Single-center Clinical Trial Evaluating the Efficacy and Safety of a Regimen Combining Chidamide With Venetoclax, Azacitidine, and Homoharringtonine in the...” NCT07643636 ↗54“A Phase Ib Study of the Safety, Pharmacokinetic of Lisaftoclax (APG-2575) Single Agent and in Combination With Homoharringtonine or Azacitidine in Patients With Relapsed/Refractory AML” NCT04501120 ↗ “An Randomized Controlled Study of Azacitidine Combined With Homoharringtonine Compared With Azacitidine for Patients With Int/High -Risk MDS and AML-MRC” NCT03978364 ↗ “Homoharringtonine (HHT) is an alkaloid and has been used in Chinese patients with acute and chronic myeloid leukemia for more than 30 years.” NCT04824924 ↗ “Efficacy and Safety of Lisafotoclax Plus Decitabine and Homoharringtonine in Venetoclax/Azacitidine Pretreated AML Patients” NCT07505160 ↗ “cytarabine (25mg/d, days1-14) and homoharringtonine (1mg/d, days1-14) by intravenous continuous infusion” NCT01417767 ↗ “Since Homoharringtonine (HHT) could downregulate MCL-1 and BCL-XL in leukemia cells” NCT04424147 ↗ “Homoharringtonine (HHT) is given by venous drip daily at 1 mg/m2 from day 1 to 7.” NCT06810791 ↗ “Homoharringtonine : 1mg/m2 per day by intravenous infusion from Day 1 to Day 7.” NCT07517510 ↗ “Homoharringtonine injection (HHT) 2-3mg d1 to d14 was intravenously injected.” NCT05584761 ↗ “Homoharringtonine (HHT) is widely used for the treatment of myeloid leukemia.” NCT06328179 ↗ |
| Known as | HHT | “In luminal cells, EIF1A knockdown and the translation inhibitor homoharringtonine (HHT) both suppress HIF-1α translation and tumor growth, while promoting infiltration of...” PMID 41707646 ↗ Feb 202615“Homoharringtonine (HHT), a plant alkaloid with antitumor properties originally identified nearly 40 years ago, has a unique mechanism of action by preventing the initial...” NCT05513131 ↗ “Homoharringtonine (HHT) is currently the only small-molecule translation elongation inhibitor approved by the U.S. Food and Drug Administration (FDA).” NCT07516704 ↗ “Our preliminary research confirmed that homoharringtonine (HHT) significantly enhances the anti-leukemia effect of Ven/AZA via inhibition of MCL-1.” NCT07517510 ↗ “Homoharringtonine (HHT) is an alkaloid and has been used in Chinese patients with acute and chronic myeloid leukemia for more than 30 years.” NCT04824924 ↗ “The induction therapy is a combination of Venetoclax(Ven), Homoharringtonine(HHT) , Cytarabine and G-CSF.” NCT06742463 ↗ “Since Homoharringtonine (HHT) could downregulate MCL-1 and BCL-XL in leukemia cells” NCT04424147 ↗ “Homoharringtonine (HHT) is given by venous drip daily at 1 mg/m2 from day 1 to 7.” NCT06810791 ↗ “Homoharringtonine (HHT) is widely used for the treatment of myeloid leukemia.” NCT06328179 ↗ “Homoharringtonine injection (HHT) 2-3mg d1 to d14 was intravenously injected.” NCT05584761 ↗ “randomized doses of homoharringtonine (HHT) during early intensification” NCT06855810 ↗ |
| Known as | HHT, Omacetaxine mepesuccinate | “HHT, Omacetaxine mepesuccinate” NCT04248595 ↗ |
| Known as | omacetaxine | “Omacetaxine mepesuccinate (omacetaxine) is a first-in-class cephalotaxine” PMID 23468307 ↗ Mar 20131“Participants are administered homoharringtonine (omacetaxine)” NCT00114959 ↗ |
| Known as | omacetaxine mepesuccinate | “homoharringtonine (omacetaxine mepesuccinate)” PMID 35274287 ↗ Mar 2022 |
| Action | Inhibit | “As a protein synthesis inhibitor” NCT04248595 ↗ |
| Modality | Small molecule | “The homoharringtonie (HHT) is a plant cytotoxic alkaloid derived from the trees of the genus Cephalotaxus.” NCT04248595 ↗ |
| Route | Intravenous | “Given IV” NCT00003694 ↗ |
| Target | MCL1 | “through reduction of MCL1 and BCL-XL” PMID 40979071 ↗ Jul 2025 |